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NCT05652647 Clinical Trial

A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men

Healthy Participants Clinical Trial

Official title:
A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]PF-07081532 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07081532 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05652647
Other study ID # C3991006
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 21, 2022
Est. completion date March 15, 2023

Study information
Verified date March 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up and processed by healthy male participants. The study consists of two parts, called study periods. In Period 1, participants will take one dose of PF-07081532 by mouth. In Period 2, participants will take one dose by mouth and one dose as an injection through a vein at the study clinic. In Period 1, participants will stay at the clinic site for up to 21 days. In Period 2, they will stay at the clinic site for 7 days. During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07081532 in participants' blood, urine, and feces samples. This will help us know how much the study medicine is getting taken in by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 12 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Key Eligibility criteria for this study include, but are not limited to the following: Inclusion criteria: Healthy Male participants must be 18 to 60 years of age, inclusive. Overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure and pulse rate measurement, standard 12-lead ECG, and laboratory tests. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures Exclusion criteria: History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerance Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). Previous administration with an investigational product (drug or vaccine) within 90 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study. Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral [14C]PF-07081532
A single oral dose of [14C]PF-07081532, will be administered as a liquid formulation in study period 1.
• Oral PF-07081532 and IV [14C]PF-07081532
In study period 2: a single, oral, unlabeled dose of PF-07081532 will be administered as a liquid formulation. Approximately 1 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-07081532 will be administered via intravenous infusion.

Locations
Country Name City State
Netherlands PRA Health Sciences Groningen

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total recovery of radioactivity in urine, feces, and emesis (if any), and both routes combined, expressed as a percent of total oral radioactive dose administered. To characterize the extent of excretion of total radioactivity in urine, feces, and emesis (if any) following administration of a single oral dose of [14C]PF-07081532. Period 1 Pre-dose to maximum Day 21
Primary Amount of metabolites of [14C]PF-07081532 in plasma, urine, and feces. To characterize the metabolic profile and identify circulating and excreted metabolites following administration of a single oral dose of [14C]PF-07081532. 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144-480 hour
Secondary AUClast of oral radiolabeled PF-07081532 in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-07081532 following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary Cmax of oral radiolabeled PF-07081532 in plasma Maximum plasma concentration of radiolabeled PF-07081532 following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary Tmax of oral radiolabeled PF-07081532 in plasma Time to Cmax of radiolabeled PF-07081532 following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary AUCinf of oral radiolabeled PF-07081532 in plasma (if data permit) Area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary t1/2 of oral radiolabeled PF-07081532 in plasma (if data permit) Terminal elimination half-life following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary AUClast of total radioactivity in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of total radioactivity following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144-480 hours post-dose
Secondary Cmax of total radioactivity in plasma Maximum plasma concentration of total radioactivity following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144-480 hours post-dose
Secondary Tmax of total radioactivity in plasma Time to Cmax of total radioactivity following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144-480 hours post-dose
Secondary AUCinf of total radioactivity in plasma (if data permit) Area under the plasma total radioactivity concentration-time profile from time zero extrapolated to infinite time following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144-480 hours post-dose
Secondary t1/2 of total radioactivity in plasma (if data permit) Terminal elimination half-life following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144-480 hours post-dose
Secondary CL/F of oral radiolabeled PF-07081532 in plasma (if data permit) Apparent clearance following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary Vz/F of oral radiolabeled PF-07081532 in plasma (if data permit) Apparent volume of distribution following administration of a single oral dose of radiolabeled PF-07081532. Period 1: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post-dose
Secondary AUClast of intravenous radiolabeled PF-07081532 in plasma Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-07081532 following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Dose normalized AUClast of intravenous radiolabeled PF-07081532 in plasma Dose normalized area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) of radiolabeled PF-07081532 following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Cmax of intravenous radiolabeled PF-07081532 in plasma Maximum plasma concentration of radiolabeled PF-07081532 following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Dose normalized Cmax of intravenous radiolabeled PF-07081532 in plasma Dose normalized maximum plasma concentration of radiolabeled PF-07081532 following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Tmax of intravenous radiolabeled PF-07081532 in plasma Time to Cmax of radiolabeled PF-07081532 following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary AUCinf of intravenous radiolabeled PF-07081532 in plasma (if data permit) Area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Dose normalized AUCinf of intravenous radiolabeled PF-07081532 in plasma (if data permit) Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary t1/2 of intravenous radiolabeled PF-07081532 in plasma (if data permit) Terminal elimination half-life following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary CL of intravenous radiolabeled PF-07081532 in plasma (if data permit) Systemic clearance following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Vss of intravenous radiolabeled PF-07081532 in plasma (if data permit) Steady-state volume of distribution following administration of a single intravenous dose of radiolabeled PF-07081532. Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Mean residence Time (MRT) of intravenous radiolabeled PF-07081532 in plasma (if data permit) Period 2: Pre-dose, 0.17, 0.25, 0.33, 0.5, 1, 3, 5, 7, 9, 11, 14, 23, 35, 47, 71, 95, 119, 143 hours post-dose
Secondary Absolute oral bioavailability (F) of PF-07081532 Dose-normalized plasma AUCinf (if data permit, otherwise AUClast) following oral unlabeled PF-07081532 compared to IV microtracer PF-07081532 in Period 2. Period 2: Pre-dose up to 144 hours post-dose
Secondary Fraction of the dose absorbed (Fa) for oral PF-07081532 Total urinary radioactivity following oral administration of radiolabeled PF-07081532 in Period 1 and IV microtracer administration of PF-07081532 in Period 2. Period 2: Pre-dose up to 144 hours post-dose
Secondary Number of participants with treatment emergent clinically significant laboratory abnormalities Baseline, day 7-21 of period 1, baseline, day 7 of period 2
Secondary Number of participants with treatment emergent clinically significant abnormal ECG measurements Pre-dose, day 7-21 of period 1, Pre-dose, day 7 of period 2
Secondary Number of participants with treatment emergent clinically significant abnormal vital measurements Pre-dose, day 7-21 of period 1, Pre-dose, day 7 of period 2
Secondary Number of participants with adverse events Pre-dose, day 7-21 of period 1, Pre-dose, day 7 of period 2
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